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Ponatinib Pregnancy and Breastfeeding Warnings

Ponatinib is also known as: Iclusig

Ponatinib Pregnancy Warnings

This drug should be used during pregnancy only when clearly necessary. AU TGA pregnancy category: D US FDA pregnancy category: Not Assigned Comments: -Based on animal studies and its mechanism of action, this drug can cause fetal harm. -Verify the pregnancy status of females of reproductive potential prior to treatment initiation. -Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the last dose. -This drug may affect the effectiveness of systemic hormonal contraceptives; direct patients to use an alternative or additional method of contraception.

Animal studies have revealed evidence of embryofetal lethality, embryofetal toxicity, and teratogenicity at maternally toxic and non-toxic doses. Adverse developmental effects were observed at exposures lower than human exposures at the recommended human dose. Animal findings (i.e., pre- and post-implantation loss of embryos at dose level corresponding to human clinical exposures) also suggest this drug may impair female fertility; it is unknown whether these effects are reversible. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Ponatinib Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for 6 days following the last dose. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -The drug amount in breastmilk is likely to be low since this drug is more than 99% bound to plasma proteins; however, this drug might accumulate in a nursing infant due to its half-life being about 24 hours. -The effects on the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Iclusig (ponatinib)." Ariad Pharmaceuticals Inc, Cambridge, MA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Iclusig (ponatinib)." Ariad Pharmaceuticals Inc, Cambridge, MA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

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